Phase I Trial, Quotient Code: QSC205947
| ISRCTN | ISRCTN97798065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97798065 |
| IRAS number | 1006953 |
| Secondary identifying numbers | IRAS 1006953, Quotient Code: QSC205947 |
- Submission date
- 17/02/2023
- Registration date
- 23/02/2023
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Principal Investigator
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 3031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public
662 Encinitas Blvd, Suite 250
Encinitas
CA 92024
United States of America
| Phone | +1 888 411 5176 |
|---|---|
| ClinicalTrials@ventyxbio.com |
Scientific
662 Encinitas Blvd, Suite 250
Encinitas
CA 92024
United States of America
| Phone | +1 888 411 5176 |
|---|---|
| ClinicalTrials@ventyxbio.com |
Study information
| Study design | Pharmacokinetics trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase I Trial, Quotient Code: QSC205947 [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) | 1. Approved 03/04/2023, Wales REC 2 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2071048222, +44 (0)2920230457, +44 (0)7920 565664; Wales.REC2@wales.nhs.uk); ref: 23/WA/0014. 2. Approved 03/04/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 57619/0001/001-0001 The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Primary outcome measure | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Secondary outcome measures | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Overall study start date | 31/01/2023 |
| Completion date | 17/11/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 20 |
| Key inclusion criteria | Healthy human volunteer |
| Key exclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 04/04/2023 |
| Date of final enrolment | 17/11/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
662 Encinitas Blvd, Suite 250
Encinitas
CA 92024
United States of America
| Phone | +1 858 232 8424 |
|---|---|
| lmedina@ventyxbio.com | |
| Website | http://www.ventyxbio.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 17/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. Results will be posted on or after the date of publication of full trial details. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials. |
Editorial Notes
05/12/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 28/07/2023 to 17/11/2023.
2. The overall study end date was changed from 28/07/2023 to 17/11/2023.
3. The intention to publish date was changed from 28/01/2026 to 17/05/2026.
05/04/2023: The HRA has confirmed that it has approved deferral.
05/04/2023: The ethics approval was added.
23/02/2023: Trial's existence confirmed by MHRA.
